European Medical Device Nomenclature
The European Medical Device Nomenclature is the nomenclature that manufacturers must use when registering their medical devices in EUDAMED.
What is the European Medical Device Nomenclature (EMDN)?
The European Medical Device Nomenclature (EMDN) was created to satisfy Article 26 of the EU Medical Device Regulation (MDR) and Article 23 of the In-vitro Diagnostics Regulation (IVDR), which states:
To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.
Manufacturers will use the EMDN when they register a medical device in EUDAMED.
Manufacturers will only have to use the EMDN once EUDAMED goes fully live.
The Medical Device Coordination Group (MDCG) contains a sub-group tasked with overseeing regulatory activities related to the EMDN. The MDCG defines the rules and processes for creating, updating, maintaining and using the EMDN.
The official version of the EMDN is available from here. The European Commission has also created an FAQ that summarises all information about the EMDN: EMDN FAQ.
What is the EMDN used for?
The primary purpose of the EMDN is to support MDR and IVDR requirements. However, it also plays a key role in MDR/IVDR device documentation and technical documentation, sampling of technical documentation conducted by notified bodies, post-market surveillance, vigilance and post-market data analysis, etc. It is also intended to support all (EUDAMED) Actors in their activities under the MDR/IVDR. Since the EMDN is publically accessible, it provides key device descriptions to patients as with regards to their own devices and all other devices available on the market that have been registered in EUDAMED.
How do I gain access to the EMDN?
The EDMN is publicly accessible online from a dedicated site. It can also be downloaded (as an Excel spreadsheet) from the same site. It is currently available in Italian and English.
How is the EMDN structured?
The EMDN is structured hierarchically to define medical devices according to categories, groups, and types. There are 7 levels in the hierarchy, with each level having a unique alphanumeric code.
What is the EMDN code?
The EMDN code is an alphanumeric code that captures the EMDN hierarchy of category, group and types (1 to 5). The EMDN code is linked with the Basic UDI-DI of the device in EUDAMED. Each code is associated with a specific description and each device must be assigned the most specific code/description.
As we can see in the example, the EMDN code is constructed from the most general (Category) to the most specific. Note: not all devices will have all 7 levels.
Note: If a code does not yet exist for a specific medical device, manufacturers must apply for it to be created.
Since the European Medical Device Nomenclature is a new concept, don’t hesitate to contact us at firstname.lastname@example.org if you have any questions about how to assign the code for your device or if you need to request a new EMDN code, if one doesn’t yet exist.